System and method for monitoring medication delivery to a patient

ABSTRACT

A care management system in which the management of the administration of care for patients is automated. Hospital information systems are monitored and the information from those systems is used in verifying the administrations of care to patients. The care management system monitors ongoing administrations for progress and automatically updates records and provides alarms when necessary. The care management system is modular in nature but is fully integrated among its modules. Particular lists of data, such as the termination times of all ongoing infusions, provide hospital staff current information for increased accuracy and efficiency in planning. Features include the automatic provision of infusion parameters to pumps for accurate and efficient configuration of the pump, and providing an alarm when an unscheduled suspension of an infusion exceeds a predetermined length of time. A passive recognition system for identifying patients and care givers is provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 10/622,983 filedJul. 18, 2003 now U.S. Pat. No. 6,915,170, which is a continuation ofapplication Ser. No. 09/114,581 filed Jul. 13, 1998, now U.S. Pat. No.6,671,563, issued Dec. 30, 2003, which is a continuation-in-part of U.S.Ser. No. 08/440,625 filed May 15, 1995 now U.S. Pat. No. 5,781,442,issued Jul. 14, 1998.

BACKGROUND OF THE INVENTION

The invention relates generally to systems for managing patient care ina health care facility, and more particularly, to systems for collectingdata and controlling the delivery of patient care.

Medical institutions are faced with a competitive environment in whichthey must constantly maintain or improve profitability and yetsimultaneously improve patient care. Several factors contribute to theever increasing costs of health care, whether it is delivered to thepatient in a hospital or out-patient clinic setting. Health caredeliverers face increased complexity in the types of treatment andservices available, but also must provide these complex treatments andservices efficiently, placing a premium on the institution's ability toprovide complex treatment while maintaining complete and detailedmedical records for each patient.

It is also advantageous to have a care management system that combinesall of the various services and units of a health care institution intoan interrelated automated system to provide “just-in-time” delivery oftherapeutic and other drugs to the patient. Such a system would preventadministering an inappropriate medication to a patient by checking themedication against a database of known allergic reactions and/orside-effects of the drug against the patent's medical history. Theinterrelated system should also provide doctors, nurses and othercare-givers with updated patient information at the bedside, notify theinstitution's pharmacy when an additional drug is required, or when ascheduled treatment is running behind schedule, and automatically updatethe institution's accounting database each time a medication or othercare is given.

Inaccurate recording of the administration of drugs and usage ofsupplies involved in a patient's treatment results in decreasingrevenues to the institution by failing to fully capture billingopportunities of these actual costs. Inadequate management also resultsin a failure to provide an accurate report of all costs involved intreating a particular illness.

In many hospitals and clinical laboratories, a bracelet device having apatient's name printed thereon is permanently affixed to a patient uponadmittance to the institution in order to identify the patient duringhis or her entire stay. Despite this safeguard, opportunities arise forpatient identification error. For example, when a blood sample is takenfrom a patient, the blood sample must be identified by manuallytranscribing the patient's name and other information from the patient'sidentification bracelet. In transferring the patient's name, a nurse ortechnician may miscopy the name or may rely on memory or a differentdata source, rather than actually reading the patient's bracelet.

Moreover, manually transferring other information, such as theparameters for configuring an infusion pump to dispense medication mayresult in errors that reduce the accuracy and/or effectiveness of drugadministration and patient care. This may result in an increasedduration of treatment with an attendant increase in costs.

Hospitals and other institutions must continuously strive to providequality patient care. Medical errors, such as where the wrong patientreceives the wrong drug at the wrong time, in the wrong dosage or evenwhere the wrong surgery is performed, are a significant problem for allhealth care facilities. Many prescription drugs and injections areidentified merely by slips of paper on which the patient's name andidentification number have been handwritten by a nurse or technician whois to administer the treatment. For a variety of reasons, such as thetransfer of patients to different beds and errors in marking the slipsof paper, the possibility arises that a patient may be given anincorrect treatment. This results in increased expense for the patientand hospital that could be prevented using an automated system to verifythat the patient is receiving the correct care.

Various solutions to these problems have been proposed, such as systemsthat use bar codes to identify patients and medications, or systemsallowing the bedside entry of patient data. While these systems haveadvanced the art significantly, even more comprehensive systems couldprove to be of greater value.

What has been needed, and heretofore unavailable, is an integrated,modular system for tracking and controlling patient care and forintegrating the patient care information with other institutionaldatabases to achieve a reliable, efficient, cost-effective delivery ofhealth care to patients. The invention fulfills these needs and others.

SUMMARY OF THE INVENTION

Briefly and in general terms, the present invention provides a new andimproved patient management system capable of monitoring, controllingand tracking the administration of care in a health care institution.

Generally, the patient management system comprises a number of CPUshaving a variety of input and output devices for receiving patient dataand for generating or displaying reports. A system of software programsoperates on the CPUs to record, process, and produce reports from adatabase whose data is representative of the care a patient receives inthe institution. The CPUs are connected together, along with at leastone dedicated file server, to form a network. Patient data is input byusers of the personal computers, and is stored in a data storage deviceconnected to the file server.

More specifically, in a more detailed aspect by way of example and notnecessarily of limitation, the patient management system includes apharmacy computer, a nursing station CPU including a video display andprinter and bedside CPUs connected to various clinical devices such asinfusion pumps for providing medication to a patient and a barcodereader for reading barcode labels either affixed to the patient'sidentification bracelet or a label on a medication container. Inoperation, the patient management system verifies that the rightmedication is being dispensed to the right patient in the right dosagevia the right delivery route at the right time by maintaining a databaseof information relating to the patient, the patient's condition, and thecourse of treatment prescribed to treat the patient's illness.

The patient wears an identification device that includes a barcode thatcan be read by a barcode reader connected to the bedside CPU. Medicationto be administered to the patient in the course of the patient'streatment is identified with a label that is printed by a barcodeprinter in the pharmacy or by the manufacturer's supplied barcodes onunit dose packaging. When the medication is administered to the patientby a care-giver, the care-giver uses the barcode reader connected to thebedside CPU to read the barcode on the patient's identification deviceand the barcode on the label identifying the medication to be dispensed.The patient management system compares the patient's identity with themedication and verifies that it is the correct medication for thepatient. Additionally, the caregiver may also have an identificationdevice that bears a barcode with the caregiver's name and otherinformation. Using the barcode reader, the care giver's identity canthus be stored in the database and linked to the treatment given to thepatient to ensure complete and accurate tracking of all treatment givento the patient.

In another aspect, an identification system is provided that is passivein nature. That is, the system operates to automatically detect andidentify an individual, such as a patient and/or caregiver without anyparticular action being required on the part of the individual. In afurther aspect, an RF transponder is mounted at a patient's room ortreatment area and automatically detects an identification device, suchas a wrist band, on the individual to identify the individual. Theidentification device may comprise an electrical circuit.

In a further aspect, the patient management system also includes thecapability of recording the present location of each clinical device inthe institution, and maintains a history of the device usage in a deviceusage and event database. This database may also include a history of adevice's maintenance and calibration.

In another aspect, the patient management system includes the ability totrack usage of consumable supplies within the various units of thehealth care institution. This assists in managing the inventory ofconsumable supplies to ensure that supplies are always available. Afurther advantage is that it enables the institution's administration toproject supply usage and thus purchase supplies in quantities thatensure cost discounts without incurring excessive inventory carryingcosts.

In yet another aspect, the patient management system employs RF (radiofrequency) transmitters and receivers to connect the various hardwareelements of the system together into a local area network. This aspectis advantageous in that it provides increased flexibility in positioningof the hardware elements of the network while eliminating the need forcostly network wiring throughout the institution.

These and other advantages of the invention will become apparent fromthe following more detailed description when taken in conjunction withthe accompanying drawings of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graphic representation of a care management systemincorporating principles of the present invention and illustratingdetails of the hardware elements and local area network;

FIG. 2 is a functional block diagram of the care system of FIG. 1additionally showing an interface with other institutional informationmanagement systems;

FIG. 3 is a functional block diagram of the software modules thatcomprise the care system of FIGS. 1 and 2;

FIG. 4 is a graphic representation of a patient identification braceletincluding a barcode that can be read by a barcode reader;

FIG. 5 is a drawing of a barcode label affixed to a medication containerthat can be read by a barcode reader;

FIG. 5A is a drawing showing a barcode label affixed to a caregiveridentity badge;

FIG. 6 is a drawing showing a sheet of barcode labels that can beaffixed to various containers or devices;

FIG. 7 is a graphical representation of a display on an infusion pumpshowing the name of a drug being infused along with other informationrelating to the infusion;

FIG. 8 presents a computer screen listing of the infusions in progressshowing the drug being administered, the time remaining, and thepatient's name;

FIG. 9 shows a patient IMAR (integrated medication administrationrecord) showing scheduled medications and windows around the scheduledtimes;

FIG. 10 shows a computer screen task list for a partial floor of ahospital in which times for administration in a certain time period areset out along with the patient name and drug to be administered;

FIG. 11 shows a computer screen used for rescheduling the administrationof an order;

FIG. 12 presents a computer screen containing an overview of a partialfloor of a hospital in which various patients' rooms are shown with thenames of the patient;

FIG. 13 is a graphical representation of another embodiment of the caremanagement system showing the clinical devices connected to the localarea network through a bedside data concentrator;

FIG. 14 is a graphical representation of still another embodiment of thecare management system showing the clinical devices transmitting andreceiving information from the local area network through RFtransmitting/receiving equipment;

FIG. 15 is a graphical representation of another embodiment of the caremanagement system of FIG. 9 where all of the hardware elements of thelocal area network communicate with each other using RFtransmitting/receiving equipment; and

FIG. 16 presents a view of a patient having an identification devicelocated on his arm that interacts with a transmitter/receiver located inthe frame of the entry/exit of the room in which the patient is located.The identification device and transmitter/receiver form a passiveidentification system in accordance with an aspect of the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, and more particularly to FIG. 1, there isshown generally an integrated hospital-wide information and caremanagement system 30 including one embodiment of the point-of-caremanagement system 30 of the present invention. The care managementsystem embodiment shown in FIG. 1 is depicted as being configured as alocal area network with a file server 45 to which are connected apharmacy computer 60, a nursing station 70, and bedside CPUs 80. Thefile server 45 stores programs and data input and collected by thevarious computers in the local area network. Various application modulesof the patient management system may be resident in each of thecomputers in the network and will be discussed in more detail below.Ethernet cabling of a local area network 50 is used to connect variousCPUs to the file server. The file server 45 also has both local andnetwork hard disk storage for storing programs as well as data gatheredon the network.

Referring now to both FIGS. 1 and 2, a functional block diagram of thepatient care management system 30 of FIG. 1 is shown in FIG. 2interfaced with and connected to other hospital information managementsystems to form an integrated information and care management system.This information and care management system is integrated with acombination of individual hospital systems, such as the pharmacyinformation system 20, and the hospital administration system 40 whichare interconnected via a network 5 and appropriate interfaces 10. Eachof the various systems 20, 30 and 40 generally comprise a combination ofhardware such as digital computers which may include one or more centralprocessing units, high speed instruction and data storage, on-line massstorage of operating software and short term storage of data, off-linelong-term storage of data, such as removable disk drive platters, CDROMs, or magnetic tape, and a variety of communication ports forconnecting to modems, local or wide area networks, such as the network5, and printers for generating reports. Such systems may also includeremote terminals including video displays and keyboards, touch screens,printers and interfaces to a variety of clinical devices. The operatingsystems and specific software applications will be described in moredetail below.

The care management system 30 of FIGS. 1 and 2 includes a file server45, such as an IBM or IBM compatible personal computer having sufficientmass storage 46, such as local hard drives, CD ROM, magnetic tape, orother media, and appropriate communication interface capabilities tointerconnect with other hardware comprising the point of care managementsystem. Although many configurations are possible, in one embodiment thefile server would include hardware such as a data communication router,a large hard drive to store data for the entire network, andcommunication hardware for communicating with the hospital network.Additionally, a separate computer (CPU) is used to communicate with,control and provide an interface gateway 27 to the hospital network 5.

A local area network 50, comprising a thin net, or ethernet cabling isused to connect the central file server 45 to the hardware thatcomprises the care management system.

In the present embodiment, the file server 45 of the care managementsystem is connected by a local area network (LAN) 50 to computers andother peripheral equipment located in the institution's pharmacy, atnursing stations located throughout the institution, and at thepatient's bedside. In the embodiment shown, the module located in thepharmacy comprises a central processing unit 60 to which is attached avideo display 64 and a keyboard 62 for entry and display of patientinformation and drug parameters. Also attached to the pharmacy CPU is abar code reader 68 which is adapted to read barcode labels that may beattached to drug containers, equipment, or caregiver identificationbadges as will be more fully discussed below. Also connected to thepharmacy CPU 60 is a bar code printer 69 and a printer 66 used forgenerating reports containing information about patient history and/orpatient treatment. The printer 66 may also be used to print barcodelabels generated by the pharmacy CPU 60 after patient or drug data isinput by a technician or pharmacist into the pharmacy computer 60 usingthe keyboard 62 or other means.

Another computer, herein referred to as the nursing CPU 70, is locatedat a nursing station. Nursing stations are typically located in varioussections and/or floors of a hospital or clinic and typically provide acentral location for record storage and monitoring for a number ofpatient beds. The nursing CPU 70 located at the nurse station typicallyincludes a video display 74 for displaying patient or other informationpertaining to the operation of the particular unit of the institution,and a keyboard 72, mouse, touch screen 73, or other means for enteringpatient data or specific commands instructing the nursing CPU 70 togenerate reports relating to either the patient's medical history or thecourse and progress of treatment for an individual patient on theattached printer 76 or on the video display 74. As will be discussedmore fully below, the nursing station CPU 70 may also generate otherreports such as, for example, a printout of drugs scheduled to beadministered to patients, productivity measurements such as, forexample, the amount of time a nurse spends with a patient or otherreports useful for assisting in the efficient operation of theparticular unit or the hospital. For example, a report listing theactual times of administration versus the scheduled times foradministration may be prepared to assist in evaluation of staffingrequirements.

Each care unit associated with the nursing station typically comprisesone of more patient beds located in private rooms, shared rooms, or openor semi-open wards that contain multiple beds. In accordance with anembodiment of the present invention, each private room, semi-privateroom, or ward area has at least one bedside CPU 80 for monitoring andtreating one or more patients. Each bedside CPU 80 has a video display84 and a keyboard 82, mouse, touch screen 83, or other device. Thebedside CPU 80 can be used by a nurse, physician or technician to accessa variety of institutional databases to display a variety of informationabout a particular patient. This information can include an on-line,real-time, graphical patient medication administration record (MAR) thatis derived from the patient's medication profile maintained by thehospital's pharmacy information system 20. The bedside CPU 80 alsoallows remote access to a patient's records stored by the file server 45to display medication history for the patient. This medication historyincludes a listing of all drug or other treatments including past,present and future deliveries to the patient. Additionally, access toadministration records of the hospital's administration system 40 isavailable through the network 5.

Each bedside CPU 80 can be connected through an appropriate interface toa variety of peripheral equipment. For example, a barcode reader 90capable of reading barcodes on a patient's wristband or medicationcontainer; an infusion pump 92 for delivering medication to the patientin a predetermined, controlled manner; or various sensors 94 that canautomatically monitor a patient's vital signs and send signalsrepresentative of these vital signs to the computer through anappropriate interface for storage and later retrieval by a selectedsoftware application to provide a graphic display of the patient's vitalsigns during the course of treatment.

A plurality of bedside CPUs are shown in the drawing; however, more orfewer may exist depending on the particular system and hospitalrequirements.

Referring now to FIG. 3, a block diagram illustrating the variousapplication software modules comprising the care management system 30 isshown. The care management system's 30 application software is modularin construction to allow installation and operation of the system withonly one or more of the application software groups present. Thisprovides flexibility in meeting the widely varying needs of individualinstitutions where cost and complexity may be an issue or where the fullsystem is not needed. Each of the modular applications, however, isfully integratible into the system.

The programs of the care management system 30 control alarms or alertsgenerated by one of the modular applications. Alarms are routedautomatically to the appropriate video display. For example, anocclusion alarm generated by a pump 92 may remain local for apredetermined period. After that period the patient's bedside computer80 may then broadcast the alarm by causing the alarm to be communicatedover the LAN 50 to alert other hospital staff of a potential problem orto cause a particular person responsible for the care of a patient, suchas, for example, a physician or nurse, to be paged.

Each of the modular applications will now be described in detail. Theoperation of each of these modular applications in a clinical settingwill be discussed more fully below. The medical administrationmanagement module 110 integrates medical order information, infusionpump monitoring, and barcode technology to support the real-timeverification and charting of medications being administered to apatient. The medical administration management module 110 creates andmaintains an on-line, real-time, patient-specific medicationadministration record (“MAR”) or integrated medication administrationrecord (“IMAR”) for each patient. This medication administration module110 contains all of the information generated in the institutionregarding the care provided to the patient. The medicationadministration management module 110 gathers information from thevarious nursing and bedside CPU's 70, 80 (FIG. 1) comprising theperipheral hardware of the care management system 30 that is distributedthroughout the institution. For example, when a physician attending apatient diagnoses an illness and determines an appropriate course oftreatment for the patient, the physician may prepare a handwrittenmedical order specifying the desired therapeutic treatment as well asany appropriate parameters such as dosage and/or period ofadministration. The written prescription is sent through theinstitutional mail system to the pharmacy where it is then entered intothe pharmacy information system 20 through a dedicated terminal, orother means, and is then entered into the care management system 30.

In another embodiment, the physician accesses the pharmacy managementsystem 20 through a dedicated terminal or through the care managementsystem 30 via the network 5 using either a nursing CPU 70 or a bedsideCPU 80. Alternatively, the treatment order may be entered by a nurse orother qualified caregiver into either the pharmacy management system 20or the care management system 30.

Referring now to FIGS. 4–6, a variety of implementations of the barcodeidentification system of the present invention are shown. FIG. 4, forexample, shows a patient identification bracelet 170 of the kindtypically used in hospitals and other institutional settings to ensurethat each patient is able to be identified even if the patient isunconscious or other-wise unable to respond to questioning. A barcode175 is printed on a label that is attached to the patient identificationbracelet 170 and has encoded within its sequence of bars the informationnecessary to identify the patient. This barcode may be read using acomputerized barcode reader 68, 90, such as those shown connected to thepharmacy CPU 60 and the bedside CPUs 80 (FIG. 1). The barcode readercomprise a light emitting and receiving wand 95 that is scanned acrossthe barcode. The light emitted by the wand 95 is reflected by thesequence of dark and light lines comprising the barcode into thereceiving lens of the wand 95. A sensor in the wand 95 converts thereceived light into a signal that is then transmitted to the CPU. Asoftware application program running on the CPU then decodes the signalinto the data represented by the barcode in a manner well known to oneskilled in the art. Using appropriate software programs, this data maythen be automatically entered into a database stored in the CPU's memoryor disk storage. While a barcode has been described for purposes ofillustration, those skilled in the art will immediately understand thatother systems, such as magnetic stripes, or programmed punched holes mayalso be used to represent data stored on each label, care giver badge orpatient wrist band.

Barcode systems are extremely flexible and the amount of informationthat can be represented by the barcode, while limited, can be used in avariety of ways. For example, as depicted in FIG. 5, a drug container185 is identified by a label 180 having a barcode 182 printed thereon.This barcode 182 can represent the patient identification and themedical order number, and any other information the institution findshelpful in dispensing the drug and tracking the treatment. The barcode182 may also be read using a barcode reader, and, using suitableapplication software such as that included within the medicaladministration management module 110, discussed below, can be used tolink the drug container and its contents with the patient identificationbracelet 170 affixed to a patient to ensure the right drug is deliveredto the right patient at the right time in the right manner. The use ofbarcodes is not limited to the implementations discussed above. A sheet190 of barcode labels 177 having barcodes 175 is shown in FIG. 6. Suchlabels can be printed by a printer connected to the pharmacy CPU 60 ofthe care management system 30 or, alternatively, by any other printerconnected to any other hospital information system that can beprogrammed to produce barcodes bearing the information in a form thatcan be read by the barcode readers connected to the various CPUs of thecare management system 30. These barcode labels 177 may then be affixedto clinical devices, patient belongings, or other items where positiveidentification is needed.

One of the key advantages of the medical administration managementmodule 110 (FIG. 3) is that the module works in concert with the barcodelabels described above. When the medication administration managementmodule 110 is implemented using the hardware system described abovecomprising a pharmacy CPU 60, barcode reader 68, and printer 66,together with a bedside CPU 80 with a connected barcode reader 90, thecare management system 30 ensures that medication is administered to theright patient, in the right dose, along the right route and at the righttime.

When the medication to be administered is of the type that is typicallydelivered to the patient using an infusion pump, the medicaladministration management module 110 automatically records the starttime of the infusion, queries the pump periodically throughout theinfusion and maintaining a continuous log of the infusion, and recordsthe end time of the infusion and the volume infused in a patient's MAR.If the infusion pump connected to the bedside CPU has a programmabledisplay, the name of the drug, as well as other important informationconcerning the progress of the infusion can be displayed on the infusionpump throughout the infusion to provide a visual display of the statusfor the infusion. One such pump is shown in FIG. 7. The particularinfusion pump depicted in FIG. 8 has three pumping channels. Two of thechannels are displaying the name of the drug being infused.

Because the medication administration management module 110 maintains anon-line, real-time, patient specific graphical medication administrationrecord that includes both past, present and future scheduledmedications, a nurse may select a scheduled dosage on the MAR andindicate that it will not be administered for specified reasons selectedfrom a list of options that are dependant upon the health status of thepatient at a particular time. This system also allows a nurse to selecta scheduled dose on the MAR, and record notes and observations about thedose selected from a list of options. The medical administrationmanagement module 110 also provides on-line, real-time help screens thatcan be accessed by a nurse or other caregiver to display specificinformation about selected medication and dose to be dispensed.

The medication administration management module 110 provides a list ofon-going infusions that can be displayed on the video display of thepharmacy CPU 60 such as is shown in FIG. 8. Drug administrations thatwill terminate within a preselected time period may be distinguishedfrom other administrations by color highlighting or other means. Thetime remaining, drug, and patient name are presented as well as buttonsfor program control.

The medication administration module 110 records and maintains in astored file a log of alerts that are generated when any discrepancy isidentified, for example, during the verification process which will bediscussed more fully below. The medication administration module 110also allows the nurse to acknowledge and correct the discrepancy inreal-time, or override the alert by entering the appropriate command.Even where the nurse is allowed to override the alert, the medicationadministration application module 110 prompts the nurse for a reason foreach alert override and then automatically enters the reason into theMAR for the patient.

The medication administration management module 110 assists the nurse orother health care professional in efficiently delivering care to thepatients by providing the ability to perform on-line queries of thepatient's MARs and produce reports designed to assist the nurse inplanning medication administration and in scheduling the workload ofdispensing the medication to the many patients for which a nursing unitis typically responsible. For example, the video display may be colorcoded to indicate the status and schedule of each drug administration,such as the patient's IMAR shown in FIG. 9. A drug delivery windowextending from thirty minutes prior and thirty minutes after thescheduled administration time may be indicated by a yellow band on thedisplay. Other reports such as the FIG. 10 task list may, for example,include scheduling of drug administrations to ensure proper medicationof the patient while distributing the workload over a period of time toensure that all medication is given promptly. The system may alsodisplay either visuals alerts on the nurse station video display 74 orproduce a printed report on the printer 76 to provide a permanent recordof any medication administration that is running late or has beenrescheduled. The medication administration module 110 may be programmedto operate in an automatic fashion, automatically providing standardreports at the nursing station at predetermined intervals, such as, forexample, every 30 minutes, as determined by the needs of the particularnursing unit and institution.

The clinical monitoring and event history module 130 shown in FIG. 3 isdesigned to monitor a variety of clinical devices attached to thenetwork in a real-time manner and provides information about thosedevices to monitoring stations located elsewhere on the network. Forexample, the clinical monitoring and event history module 130 can beconfigured to monitor a plurality of clinical devices that are in use todeliver medication to patients in the private rooms, semi-private roomsor ward areas in a nursing unit. The clinical monitoring and eventhistory module 130 retrieves real-time data from each device, anddisplays a visual representation of each device including allsignificant data related to its status and settings on the video display74 connected to the Nursing CPU 70 (FIGS. 1 and 2). For example, in thecase where the clinical monitoring and event history module 130 ismonitoring an infusion pump 92, a nurse at the nursing station canaccess the status for that pump wherein the display 74 attached to thenurse CPU 70 then displays information regarding the status of theinfusion being performed at that time. For example, information caninclude the name of the drug being infused, the patient's name, thescheduled start, the actual start of infusion, the scheduled end ofinfusion, the projected end of infusion, the amount of drug infused, theamount of drug remaining to be infused and any alert or discrepancyconditions that may need attention by the nurse. Because the caremanagement system 30 is a fully integrated system, the medicaladministration management module 110 works in concert with the clinicalmonitoring and event history module 130 so that a nurse, doctor ortechnician may, after evaluating the status of the infusion displayed oneither the video display 74 at the nursing CPU 70 or on the videodisplay 84 at the bedside CPU 80 may, by using the touch screen 73, 83of the computer, adjust the infusion regimen accordingly using, forexample, a screen displayed on the video display 74, 84 as shown in FIG.11.

The clinical monitoring event history module 130 may also be programmedto immediately display alarm conditions on remote monitoring screens,such as the video display 74 attached to the nursing CPU 70, as thealarm occurs. For example, the status of each patient's infusion can berepresented on a video display at the nursing station as shown by theOVERVIEW computer screen in FIG. 12. When an alert occurs, the boxrepresenting the patient' room flashes red to attract attention to thealert. Displaying the alarm condition in this manner allows a nurse toquickly and easily identify the patient from the nursing station andtake appropriate action to address the condition causing the alarm. Thesystem may also be programmed to display certain alarms that have beenidentified as particularly important events at other video displayslocated throughout the institution, such as the video display 64attached to the pharmacy CPU 60 located in the institution's pharmacy.The manner of overview display in FIG. 12 also facilitates recordupdate. For example, when patients move rooms, clicking on the patient'sname, dragging that patient to the new room, and unclicking will causethe records to reflect the patient's move and the display will now showthe patient in that room.

The clinical device tracking and reporting module 120 shown in FIG. 3 isused to maintain a record of the location of each clinical device andthe history of its use in the institution. This system maintains arecord of the current or last known location within the institution ofeach clinical device used in the institution, such as an infusion pumpor vital sign sensor. Thus, the appropriate equipment can be easilylocated by a nurse or a technician for a given therapy regimen or vitalsign measurement. This is particularly useful in a large hospital orclinic having many patient rooms, patient beds, or treatment areas whereequipment may be temporarily misplaced. This system is also useful inthose particular instances where an emergency occurs where treatmentrequires a particular piece of equipment. The status of that equipmentcan be easily ascertained from a remote video terminal, such as thevideo display 74 connected to the nursing CPU 70.

The clinical device tracking and reporting module 120 also maintains arecord containing the usage history of each clinical device, includinginformation about the patient it was used to treat, its location, thedate, time, duration of use, any alarms that occurred and whatmedications were dispensed. This history may also contain themaintenance and calibration records for a clinical device. Suchinformation can be queried on-line by technicians, nurses or otherhospital administration personnel to generate reports to assist inlocating the clinical device, report on the historical usage of thedevice, and to provide a log of preventative maintenance and equipmentcalibration. The efficient calibration of complex and sensitive clinicaldevices is particularly important in a heath care institution tomaintain accuracy and quality of therapeutic treatment delivery.Maintaining a history of the usage of the device is also helpful tojustify purchasing additional clinical devices when needed, or where therecord indicates that a particular clinical device has become obsoleteand needs to be replaced by a newer model of the device.

The care management system 30 also includes a consumable tracking module140 that maintains a record of all consumable item usage for treatmentof each patient. This record ensures that appropriate supplies areordered and delivered to the nursing unit in a timely and cost-efficientmanner to prevent outages of necessary supplies. Such information mayalso be used by the hospital inventory systems through an appropriateinterface or other management system to ensure that the supplypurchasing is done as cost-effectively as possible. The consumabletracking module 140 provides on-line queries and report generationsummarizing consumable uses for a particular patient, a particularnursing unit, or a variety of other purposes.

The unit management tool module 150 assists nurses in sharinginformation related to patients and automates routine transactionswithin the nursing unit. The unit management tool module 150 allows anurse to record the allergies, handicaps, and special care needs of thepatient which, cooperating with the medication administration recordmodule 110 and the clinical monitoring and event history module 130,displays that information prominently on all appropriate displayscreens, either at the pharmacy video display 64, the nursing videodisplay 74 or at the bedside video display 84 (FIG. 1). The unitmanagement tools module 150 also allows a nurse to record patienttransfers and the times when the patient is out of the room or off thefloor, such as, for example, when the patient is transferred to surgeryor to a different part of the institution for a particular kind oftreatment such as rehabilitative therapy. This system may also beprogrammed to signal an alarm when a patient has been disconnected fromthe system longer than scheduled, for example, when the patientdisconnects from the infusion to attend to personal hygiene. Thisfunction ensures that an alarm or alert is sounded and that appropriatepersonnel are notified of any potential problems and can take thenecessary actions to alleviate the alert condition.

The knowledge resource tools module 160 provides a framework forinformation sharing among the various units in the hospital and alsosupports an assortment of everyday tools to used by the nurses,physicians and technicians involved in the delivery of health carewithin the institution. This module allows or assists in integratingexternal information sources into the care system 30 to improve theeffectiveness of the care management team in treating the patients inthe institution.

For example, the knowledge resource tools module 160 provides a varietyof on-line tools including, for example, a calculator, a dose ratecalculator for calculating the appropriate dosage and infusion rate fora particular drug to be infused into a patient, a standard measurementconversion calculator for converting between units of measurement, askin surface area calculator, and a timer and stopwatch. These resourcesmay be displayed on the video displays 64, 74, 84 at appropriate pointswithin the system, and are available from any CPU either in thepharmacy, at the nursing station or at the bedside. These applicationtools can be programmed to appear on the video display 64, 74, 84 eitherautomatically, such as, for example, when an infusion pump is configuredat the start of an infusion to assist in the calculation of a dose rate.These resources may also be available upon entry of the appropriatecommand by a nurse, physician or technician.

Referring once again to FIG. 2, a device management subsystem 192 isshown and comprises a microcomputer. The subsystem monitors the statusof the clinical devices, such as the pumps. Alternately, the subsystem192 may be included in another microcomputer, such as a bedside CPU 80.

The background monitoring system 195 may also be disposed in astand-alone microcomputer or may be incorporated in an existingmicrocomputer. The subsystem performs background tasks such asmonitoring the status of the interface gateway 27.

As depicted in FIG. 2, the care management system 30 is connected toother systems in the institution via an interface 10. This interface maysupport standard health level 7 (HL7) interfaces to the hospital's otherinformation systems and can also support custom interfaces to systems ordevices that do not support the HL7 standard. The system interfaces maybe either real-time or batch mode, although a real-time interface to ahospital's pharmacy system is required to support the on-line medicaladministration records keeping function of the medical administrationmanagement module 110.

The care management system software can be written to operate on avariety of operating systems to suit the needs of a variety ofinstitutions. In a present embodiment, the software is written tointerface with the nurses and physicians using the Windows environment(Windows is a trademark of Microsoft, Inc.) on IBM compatiblemicro-computers. The Windows environment is well-known by those skilledin the art and will not be described in detail herein. The caremanagement system software, when implemented using the Windows system,is particularly useful in that the Windows operating system provides theability to load several programs at once. Multitasking programs,allowing several application programs to run simultaneously yetproviding immediate access to the various software modules of the caremanagement system 30 may also be used.

One particular mode of operation of the care management system will nowbe described. As described above, a patient entering a hospital or othercare-giving institution is provided with a wristband necklace, ankleband or other identifier that is affixed to the patient in a manner sothat the patient can be identified even if the patient is unconscious orotherwise unresponsive. Such a wristband 170 is depicted in FIG. 4. Inone embodiment, the wristband 170 barcode represents the name of thepatient and other information that the institute has determined isimportant and also includes a barcode 175. The information printed uponthe band, such as name, age, allergies or other vital information isencoded into the barcode 175.

After the patient is admitted and situated in a bed within theinstitution, the patient is typically evaluated by a physician and acourse of treatment is prescribed. The physician prescribes the courseof treatment by preparing an order, which may request a series oflaboratory tests or administration of a particular medication to thepatient. The physician typically prepares the order by filling in a formor writing the order on a slip of paper to be entered into thehospital's system for providing care.

If the order is for administration of a particular medication regimen,the order will be transmitted to the institution's pharmacy. The orderwill arrive in written form at the pharmacy, will be evaluated by thepharmacy and processed. The pharmacy then prepares the medicationaccording to the requirements of the physician. The pharmacy packagesthe medication in a container, such as the container 185 shown in FIG.5. Normally, a copy of the order, or at a minimum, the patient's name,the drug name, and the appropriate treatment parameters are representedon a label that is then affixed to the drug container 185. According toone embodiment of the present invention, this information is representedby a barcode 182, that is then printed on a label 180. This barcodelabel 182 may be automatically generated using a printer capable ofprinting barcodes, such as, for example, a printer 69 attached to thehospital's pharmacy information system 20. The existence of thismedication order is made available by the hospital's pharmacyinformation system 20 and is stored by the file server 45.

Generally, the medication is then delivered to the appropriatecaregiving unit for administering to the patient. A nurse or techniciancarries the drug container 185 to the appropriate patient. In accordancewith one embodiment of the present invention, the nurse or technicianfirst read the barcode 175 on the patient ID bracelet 170 using thebarcode reader 90 connected to the bedside CPU 80. The nurse ortechnician would then read the barcode 182 on the label 180 affixed tothe drug container by swiping the barcode wand 95 across the barcode 182printed on the label 180 of the drug container 185. Additionally, arecord of the identity of the caregiver dispensing the medication may beobtained by reading the barcode 205 printed on an identity badge 200(FIG. 5A) typically worn by all institution personnel.

For certain drugs, the care-giver is prompted to enter data descriptiveof a selected patient parameter or parameters, such a laboratory valueor a current vital sign, before completing the verification process. Forexample, the care-giver may be prompted to measure and enter a value fora patient's blood pressure before administering certain selected drugs.The system may include ranges of acceptable values for the parameters.If the system detects an out-of-range value for the parameter, thesystem causes an alarm to be provided. In an alternative embodiment, theparameters could be monitored and entered into the system automatically,eliminating the need for manual entry by the care-giver.

The data obtained then is analyzed by the medication administrationmanagement module 110 which records the therapeutic regimen informationin the patient's MAR, and verifies that the right medication is beinggiven to the right patient in the right dose by the right route and atthe right time. If the medication administration management module 110detects a discrepancy between the barcoded information printed on thepatient bracelet 170 and the barcoded information on the label 180affixed to the medication container 185, an alert is sounded and theappropriate information is displayed on the video display 84 attached tothe bedside CPU 80. The nurse or technician then either corrects thediscrepancy by either re-reading the barcode 175 on the patient'sbracelet 170 and the barcode 182 on the medication container 185 or,alternatively, by entering the appropriate information into the bedsideCPU 80 using the keyboard 82 or touch screen 83, mouse, or other device.In the event that the nurse or technician determines that thediscrepancy cannot be automatically corrected by re-reading the barcodesand that the discrepancy is minor and will not affect the accuracy orsafety of the delivery of the medication, the nurse or technician mayoverride the alert.

In an embodiment of the present invention, where the medication is to bedelivered using an infusion pump, such as the infusion pumps 92 attachedto the bedside CPU 80, the care management system automaticallydownloads information consisting of the appropriate configurationparameters for the infusion from the pharmacy CPU 60 through the localarea network 50 into the bedside CPU 80 and then into the infusion pump92 when the verification function of the medical administrationmanagement module 110 is complete. This is particularly advantageous inthat one potential source of inaccuracy is eliminated by automaticallyconfiguring the pump, thus eliminating the need for the nurse ortechnician to manually enter the parameters necessary to configure theinfusion pump 92. In one embodiment, the infusion pumps 92 comprise IVACCorporation Model 570 volumetric pumps. In an embodiment where the pumpscannot be automatically configured by downloading parameters from thenetwork, the care management system 30 only verifies that the righttreatment is being administered to the right patient. The pump must thenbe manually configured by the physician, nurse or technician.

Once the infusion pump is configured, the technician then starts theinfusion by pressing the appropriate control on the infusion pump 92.Starting pump that is capable of being monitored automatically by thecare management system 30 causes a signal to be transmitted from thepump to the bedside CPU 80 which is then logged by the clinicalmonitoring and event history module 130 and entered by the medicaladministration management module 110 into the patient's MAR. In the casewhere the institution is using a pump that is not capable of beingconfigured by downloading parameters from the network, the nurse orother caregiver logs the start of the infusion using the touch screendevice, mouse or other device connected to the bedside CPU 80. In thiscase, the video displays of the care management system 30 that displayinformation about the status of the infusion will not display real-timedata. Rather, the care management system 30 will project what the statusof the infusion should be given the infusion parameters, the timeelapsed since the infusion began, and any other events that weremanually logged by the caregiver that may have affected the progress ofthe infusion.

The care management system 30, utilizing the application modulesdescribed above, monitors the infusion process in a real-time manner,providing alerts on the appropriate video display screens locatedthroughout the institution and allows intervention by nurses or othercaregivers at remote locations if necessary. If the pharmacy managementsystem 20 is directly linked to the care management system 30, the caremanagement system 30 may also provide a scheduling report to thepharmacy in determining the status of ongoing infusions, as well as inscheduling the preparing of medications for future infusions.

In another embodiment, the present invention includes a “Code Mode” thatallows a care-giver to bypass the system to immediately cause a list ofdrugs that have been preselected by the institution to be used in anemergency situation. The initiation of the “Code Mode” causes atime-stamp to be placed in the patient's MAR along with the identity ofthe drug selected from the displayed list of drugs to be used to treatthe emergency. This feature ensures that the emergency, and thetreatment used to address the emergency, are accurately recorded in thepatient's MAR.

While one particular embodiment of the present invention has beendescribed above, alternative configurations of the care managementsystem network are possible. For example, one alternative embodiment ofthe care management system 30 is depicted in FIG. 13. In thisconfiguration, clinical devices 210 are connected by means ofappropriate interfaces and cabling 215 to a bedside data concentrator220 which would typically be located outside of a private room,semi-private room or ward area. In this configuration, there is nobedside CPU 80 as described previously. Instead, the bedside dataconcentrator 220 is connected through an appropriate interface andcabling to the local area network 50, where the data gathered from theclinical devices 210 is then available for processing by the caremanagement system 30 and display at the various monitoring stations,such as either in the pharmacy or at the nurse station 70. In thisembodiment, there is no bedside CPU 80 having a keyboard 82 for dataentry or a video display 84 for display of either clinical deviceinformation or patient information.

A further embodiment of the care management system 30 local area networkis depicted in FIG. 14. In this embodiment, the file server andmonitoring stations are connected using appropriate interfaces andethernet cabling to an RF data concentrator 225. At the bedsidelocations in the private rooms, semi-private rooms or ward areas of theinstitution, the clinical devices 210 and barcode reader 90 at thebedside are connected to an RF transmitter/receiver 230. This RFtransmitter/receiver 230 transmits the information gathered from theclinical devices 210 and the barcode reader 90 to the RF dataconcentrator 225 attached to the local area network 50. Thus, expensivecabling is not required to connect every patient treatment area.Additionally, flexibility in locating the clinical devices 210 andbarcode reader 90 is obtained as well as allowing the ability toreconfigure the patient treatment area without costly rewiring of theethernet cabling.

Yet another embodiment of the care management system 30 local areanetwork 50 configuration is shown in FIG. 15. In this configuration, theethernet cabling connecting the pharmacy CPU, the nurse station nursingCPU 70 and bedside CPUs and clinical devices is eliminated entirely.Each hardware element, comprising the file server, nursing CPU 70,pharmacy CPU 60 and bedside CPUs 80 and clinical devices and/or barcodereaders is connected to an RF transmitter/receiver 230. In this manner,all of the information is transmitted throughout the local area network50 by way of radio transmission rather than by using costly networkcabling. Such a system would additionally allow for the use of portablecomputers 235 having RF transmitter/receivers 230 that could then becarried with physicians, nurses or technicians as they circulate throughthe institution. With this configuration, caregiving personnel couldaccess the care management system either spontaneously or uponnotification of an alert no matter where they were in the institution atany given time. Such a system would be particularly useful in a largeinstitution where caregiving personnel are likely to be responsible formany hospital beds or when personnel are out of the area or off thefloor.

Another embodiment of the care management system 30 is shown in FIG. 16.In this embodiment, the patient 245 and/or caregiver have badges orwrist bands 240 that may also include electronic circuitry that isresponsive to signals from a transmitter/receiver 230 located in eachpatient room or treatment area to automatically provide the caremanagement system 30 (FIG. 1) with the identity of, and possibly otherselected information about, the occupants of the patient room ortreatment area, eliminating the need to use a bar-code reader to readthe bar-codes on the patient and/or caregiver badges or wrist bands.Such a system may be described as a passive recognition system in thatneither the patient nor the caregiver need take any active steps toinform the care management system 30 of their location within theinstitution.

One example of such a system incorporates an intelligent RF computerchip into the caregiver or patient badge or wristband 240 that providesa unique, or programmed response with a passive RF transponder 230located within a patient room or treatment area, such as in the frame231 of the entry or exit of the room or treatment area, or mounted on awall or ceiling. Each badge or wrist band 240 interacts with signals ofthe transponder 230 in a unique way, the unique interaction representingan assigned code for the badge or wristband 240. Utilizing thistechnology would remove manual steps and some of the “human factor” fromthe process of identifying the patient and caregiver.

When an individual 245 wearing a badge or wristband 240 having such acircuit enters a room or area where a transmitter/receiver 230 islocated, the electronic circuit in the badge or wristband 240 interactswith signals emitted by the transmitter without any positive action onthe part of the caregiver or the patient. This interaction may be sensedby the receiver, which may be capable of determining the identity of thebadge or wristband 240 from the interaction of the electronic circuitwith the emitted signals. Alternatively, the receiver may simply sensethe interaction and provide a signal representative of the sensedinteraction to a computer or other processor which has been programmedor otherwise configured to determine the identity of the individualassociated with that particular badge or wristband 240.

Although the preceding paragraphs describe a passive recognition systemusing electrical circuitry, other approaches may also be used. Forexample, it can be envisioned that the patient and/or caregiver may havemagnetically-encoded devices that can be automatically read by anappropriate detector located in the patient room or treatment area.

Such a system is advantageous in that it can also be used to track thelocation of patients and caregivers in an institution. This informationwould be useful to monitor patient movements, especially in the case ofpatients with reduced mental capacity who may be prone to wanderingabout the institution. It would also be useful to know the location ofthe caregivers within an institution so that in the event of anemergency, the caregiver could be quickly located.

While several forms of the invention have been illustrated anddescribed, it will also be apparent that various modifications can bemade without departing from the spirit and scope of the invention.Accordingly, it is not intended that the application be limited, exceptby the appended claims.

1. A system for monitoring the delivery of medication to a patient by aclinical device, comprising: a first processor in operable communicationwith the clinical device; input means operatively connected to the firstprocessor for input of information related to the delivery of medicationto the first processor; a second processor having a memory in which isstored a record associated with the patient containing patientinformation, including patient condition information, and informationrelated to the delivery of medication to the patient; means forgenerating patient condition information; means for communicatinginformation related to the delivery of medication to the patient betweenthe first and second processors, the information includingidentification data, clinical device operating parameters and medicationdelivery information, the means for communicating also for communicatingthe patient condition information to the second processor for storage inthe record associated with the patient; wherein identification datainput into the first processor is compared to the stored identificationdata by either the first or second processor and the second processordownloads clinical device operating parameters to the first processor toprogram and operate the clinical device in accordance with thedownloaded operating parameters if the comparison of the identificationdata satisfies a predetermined condition.
 2. The system of claim 1,wherein the means for generating patient condition information is avital sign monitor.
 3. The system of claim 1, wherein the means forgenerating patient condition information is a laboratory test.
 4. Thesystem of claim 2, wherein the second processor monitors the patientcondition information and indicates a discrepancy condition if a valueof a vital sign parameter is outside of a range of predeterminedacceptable values for the vital sign parameter.
 5. The system of claim3, wherein the second processor monitors the patient conditioninformation and indicates a discrepancy condition if a value of alaboratory test is outside of a range of predetermined acceptable valuesfor the laboratory test.
 6. A method for monitoring the delivery ofmedication to a patient by a clinical device, comprising: storinginformation related to the delivery of medication to a patient in arecord associated with the patient in a memory; sensing informationrelated to the delivery of medication to a patient from anidentification device associated with a patient; comparing the sensedinformation with the stored information; communicating clinicaloperating parameters to the clinical device to program the clinicaldevice if the comparison of the sensed information with the storedinformation satisfies a predetermined condition; operating the clinicaldevice in accordance with clinical operating parameters; monitoring acondition of the patient; storing information related to the conditionof the patient in the record associated with the patient.
 7. The methodof claim 6, wherein monitoring the condition of the patient includesmonitoring values generated by a vital sign monitor.
 8. The method ofclaim 7, wherein monitoring the values generated by the vital signmonitor includes comparing the monitored values to a predetermined rangeof acceptable vital sign values and indicating a discrepancy if an outof range vital sign value is detected.
 9. The method of claim 6, whereinmonitoring the condition of the patient includes monitoring values oflaboratory tests, comparing the monitored values to a predeterminedrange of acceptable laboratory test values and indicating a discrepancyif an out of range laboratory test value is detected.
 10. A method foradjusting the delivery of medication to a patient by a clinical device,comprising: programming a processor to operate a clinical device inaccordance with selected clinical operating parameters; monitoring acondition of the patient; communicating the condition of the patient tothe processor; analyzing the communicated condition of the patient usingthe processor to detect whether the condition of the patient is within arange of predetermined acceptable values of the condition of thepatient; determining, with the processor, at least one of the selectedclinical operating parameters to adjust to attempt to bring themonitored condition of the patient within the range of acceptable valuesand determining an adjusted at least one of the selection clinicaloperating parameters; and operating the clinical device in accordancewith the adjusted at least one of the selected clinical operatingparameters.